Post Quantum Secure Pharmacovigilance

---
name: post-quantum-secure-pharmacovigilance
description: "NIST-standard PQC migration (ML-KEM + ML-DSA) for pharmacovigilance and healthcare data systems. Use when designing post-quantum security for adverse event reporting, clinical observation systems, or any healthcare pipeline handling sensitive patient data that needs quantum-resistant cryptography."
metadata:
  arxiv_id: "2606.09412"
  published: "2026-06-09"
  authors: "Saee Desai, Tom Shimoni, Eddie Cameron, David Akamine, Aniketh Chunduri"
  tags: [post-quantum-cryptography, pharmacovigilance, ML-KEM, ML-DSA, healthcare-security]
---

# Post-Quantum Secure Pharmacovigilance

## Core Framework

This paper presents the first practical PQC migration framework for pharmacovigilance systems — critical infrastructure handling adverse drug reaction reports, clinical trial data, and patient safety information.

### Key Components

1. **ML-KEM (CRYSTALS-Kyber)**: Post-quantum key encapsulation for encrypting pharmacovigilance data in transit. Replaces RSA/ECDH in the E2E pipeline.
2. **ML-DSA (CRYSTALS-Dilithium)**: Post-quantum digital signatures for authenticating adverse event reports and ensuring non-repudiation of submissions.
3. **Hybrid TLS Migration**: Gradual migration strategy combining classical + PQC algorithms during transition period, ensuring backward compatibility with legacy healthcare systems.

### Security Properties

- **Confidentiality**: ML-KEM-768 provides NIST Level 3 security (equivalent to AES-256)
- **Integrity**: ML-DSA-65 provides authenticated report submission
- **Harvest-now-decrypt-later protection**: Even if adversaries harvest encrypted pharmacovigilance data today, they cannot decrypt it with future quantum computers

### Activation

- 药品安全, pharmacovigilance security, post-quantum healthcare
- ML-KEM, ML-DSA, CRYSTALS migration
- 抗量子药物监测, quantum-resistant adverse event system
- healthcare data encryption, PQC migration

## Implementation Patterns

### Pattern 1: Secure Adverse Event Submission Pipeline

```
Reporter → ML-DSA signature verification → ML-KEM encrypted channel → Central PV Database
```

### Pattern 2: Hybrid TLS for Healthcare Interoperability

During migration, support both:
- Classical TLS 1.3 (ECDHE + AES-256-GCM)
- Hybrid TLS 1.3 (X25519 + ML-KEM-768, AES-256-GCM)

## Pitfalls

- **Regulatory compliance**: FDA/EMA pharmacovigilance systems have strict validation requirements — PQC migration must not alter data integrity guarantees
- **Performance overhead**: ML-KEM key exchange adds ~2-3ms latency; ML-DSA signature verification adds ~1ms — acceptable for most PV workflows but test with high-volume systems
- **Key size**: ML-KEM-768 ciphertexts are 1088 bytes (vs 32 bytes for X25519) — may impact bandwidth-constrained IoMT devices

## References

- arXiv: 2606.09412 - "Towards Post-Quantum Secure Pharmacovigilance with ML-KEM and ML-DSA"
- NIST FIPS 203 (ML-KEM) and FIPS 204 (ML-DSA)